Measuring Development of Brain Responses to Vocal Sounds in Babies of Mums With Mental Illness

NCT04350294 | Unknown

• 1 other identifier: 212715
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

CAPRI-Voc examines the differences in how speech and environmental sounds are processed in the infant brain as they grow from 9 to 12 months. The main aim of our research is to see whether serious mental illness or other factors influence this development in children. This means we are looking for new mums and their infants who have not experienced mental illness.

Conditions

Mental Disorders, Severe

Keywords

Psychosis; Schizophrenia; Depression; Bipolar; Anxiety; Obsessive Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

• functional near infrared spectroscopy (fNIRS) to assess changes in neural responses over time

  Baby will listen to vocal, non vocal, and emotional speech sounds for around 12 minutes. fNIRS uses near infrared light to capture changes in blood oxygenation in response to the sounds which is analogous to brain function. We are only assessing brain responses to the auditory stimuli played, a video is used to keep the baby's attention on the task

  When the child is 9 months and 12 months old

Secondary Outcomes (1)

• Bayley scale of infant and toddler development III

  When the child is 12 months old

Study Arms (2)

Serious Mental Illness *RECRUITMENT IN THIS GROUP IS CLOSED

Mothers with a serious mental illness\* \*received hospitalisation, treatment or intervention from a secondary care (mental health) service in the last 5 years.

Healthy Controls

Mothers with no history of mental illness, who have given birth since February 2021

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We are interested in recruiting all women who have given birth since February 2021\* Please contact the our team if you have any questions about your suitability for the study.

You may qualify if:

• Capacity to consent for themselves and their baby
• Proficiency in English

You may not qualify if:

• Women whose baby is permanently removed from their care
• Women with a primary diagnosis of substance/alcohol abuse or dependence in the last year
• Women with a primary diagnosis of anorexia/bulimia nervosa
• Women with a primary diagnosis of a personality disorder, psychological development or somatoform disorders
• Infants with congenital malformations, severe chronic illness, and developmental disorders

Sponsors & Collaborators

• University of Manchester: lead
• European Research Council: collaborator

Study Sites (1)

University of Manchester

Manchester, Greater Manchester, M13 9PL, United Kingdom

RECRUITING

Related Links

• CAPRI-Voc website

MeSH Terms

Conditions

Mental Disorders; Psychotic Disorders; Schizophrenia; Depression; Anxiety Disorders; Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Behavioral Symptoms; Behavior

Study Officials

• Kathryn M Abel

  University of Manchester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucy Stibbs-Eaton

CONTACT

(+44) 07771 396 433; capri@manchester.ac.uk

Jennifer Crowell

CONTACT

(+44) 07771 396 433; capri@manchester.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 17, 2020
• Study Start: September 1, 2017
• Primary Completion: April 20, 2022
• Study Completion: October 20, 2022
• Last Updated: October 12, 2021

Record last verified: 2021-10

Locations

GB (1)